Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
NCT ID: NCT02730377
Last Updated: 2020-07-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1991 participants
INTERVENTIONAL
2016-03-28
2019-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liraglutide 1.8 mg
Add-on to metformin
liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Interventions
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liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
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Haleyville, Alabama, United States
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Tuscumbia, Alabama, United States
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Fountain Hills, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Harrisburg, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Alhambra, California, United States
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Buena Park, California, United States
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Carlsbad, California, United States
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Costa Mesa, California, United States
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Elk Grove, California, United States
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Encinitas, California, United States
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Huntington Beach, California, United States
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La Mirada, California, United States
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Lancaster, California, United States
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Lomita, California, United States
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Montclair, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Killeen, Texas, United States
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Longview, Texas, United States
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Missouri City, Texas, United States
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New Braunfels, Texas, United States
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Surrey, British Columbia, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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Truro, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Sarnia, Ontario, Canada
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Strathroy, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
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Québec, , Canada
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Bogotá, , Colombia
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Bogotá, , Colombia
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Medellín, , Colombia
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Bangalore, Karnataka, India
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Mysore, Karnataka, India
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Indore, Madhya Pradesh, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Noida, Uttar Pradesh, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Hubli, , India
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Ludhiana, , India
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Riga, , Latvia
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Riga, , Latvia
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Tukums, , Latvia
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Beirut, , Lebanon
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Byblos, , Lebanon
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El Achrafiyé, , Lebanon
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Hazmiyeh, , Lebanon
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Toa Baja, , Puerto Rico
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Trujillo Alto, , Puerto Rico
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Dzerzhinskiy, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Adapazarı, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Countries
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References
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Unger J, Allison DC, Carlton M, Lakkole K, Lowe D, Murphy G, Panda JK, Sargin M, Kaltoft M, Treppendahl MB, Zoghbi M; LIRA-PRIME global panel. Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting. Diabetes Obes Metab. 2019 Jul;21(7):1543-1550. doi: 10.1111/dom.13682. Epub 2019 Mar 26.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2015-002417-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1170-7035
Identifier Type: OTHER
Identifier Source: secondary_id
NN2211-4232
Identifier Type: -
Identifier Source: org_study_id
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